Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: APPLE Study (APPendicitis and Laparoscopic Evaluation) Study; Multicenter Prospective Validation of the Laparoscopic APPendicitis (LAPP) Score
Brief Summary:
SUMMARY
Rationale: A diagnostic laparoscopy is a frequently used method to confirm the diagnosis appendicitis. However until recently evidence-based laparoscopic criteria for determining appendicitis were not defined. If there is any doubt about the presence of appendicitis the appendix is usually removed. In a single centre prospective pilot study on 134 patients the investigators were able to define the Laparoscopic APPendicitis (LAPP) score. In the current study the investigators will validate the LAPP score in order to decrease the negative appendectomy rate by 50%. Eventually the score should lead to a decrease in morbidity.
Objective: To decrease the negative appendectomy rate by 50%.
Study design: A multicenter prospective validation study
Study population: All patients, ≥18 years, operated with a diagnostic laparoscopy for the clinical suspicion appendicitis. Sample size calculation, performed by a statistician/ epidemiologist of the Trial Coordination Centre, showed the need to analyse 778 patients.
Intervention (if applicable): Patients operated on appendicitis in 2008 and 2009 (n=843), were retrospectively analysed for negative appendectomies. This cohort will serve as the control group. In this control group no intervention was given, as the LAPP score was not yet defined.
In the 778 prospective analysed patients, the LAPP score will be used during a diagnostic laparoscopy. With the LAPP score the investigators intend to halve the number of negative appendectomies.
Main study parameters/endpoints: A decrease in the negative appendectomy rate from 9% to 5%. Thi